| HPLC法测定尼莫地平软胶囊的含量及有关物质 |
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| 引用本文： | 郝桂明,华莲,唐素芳.HPLC法测定尼莫地平软胶囊的含量及有关物质[J].药物分析杂志,2012(3):464-467. |
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| 作者姓名： | 郝桂明 华莲 唐素芳 |
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| 作者单位： | 天津市药品检验所 |
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| 摘 要： | 目的:建立HPLC法测定尼莫地平软胶囊的有关物质及含量。方法:采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-乙腈-水(35∶38∶27)为流动相,流速1.0mL.min-1,柱温为40℃,检测波长为235 nm。结果:尼莫地平和杂质A均在0.1～4.0μg.mL-1浓度范围内与其峰面积呈良好线性关系(r=1.0000),最低检出限均为0.4 ng。高、中、低3种浓度的平均回收率为99.6%,RSD为0.5%(n=9)。结论:该方法简便准确,重复性好,可用于尼莫地平软胶囊的有关物质和含量测定。
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| 关 键 词： | 钙拮抗剂 尼莫地平软胶囊 光降解产物 杂质 质量控制 标准提高 高效液相色谱法 |
HPLC determination of nimodipine soft capsules and its related substances |
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| HAO Gui-ming,HUA Lian,TANG Su-fang.HPLC determination of nimodipine soft capsules and its related substances[J].Chinese Journal of Pharmaceutical Analysis,2012(3):464-467. |
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| Authors: | HAO Gui-ming HUA Lian TANG Su-fang |
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| Institution: | (Tianjin Institute for Drug Control,Tianjin 300070,China) |
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| Abstract: | Objective:To establish an RP-HPLC method for determination of the related substances and the content of nimodipine soft capsules.Method:The chromatographic separation was achived on a Diamonsil C18(250 mm×4.6 mm,5 μm)Column with the mobile phase of methanol-acetonitrile-water(35∶ 38∶ 27).The flow rate was 1.0 mL·min-1with column temperature at 40 ℃.The detection wavelength was 235 nm.Results:The calibration curve was linear within the range of was 0.1-40 μg·mL-1for nimodipine and 0.1-4.0 μg·mL-1(r=0.999 99)for nimodipine related compound A.The average recoveries were 99.6% and RSD was 0.5%(n=9).Conclusion:The method is simple,accurate and reproducible for determination of nimodipine soft capsules. |
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| Keywords: | calcium antagonists nimodipine soft capsules photodegradation product impurity quality control standard improvement HPLC |
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